This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

A Phase III, Open-label, Randomized Parallel-group Study on the Immunogenicity and Safety of Quinvaxem® DTwP-HepB-Hib) in Uniject™ With Quinvaxem® Monodose Vials in Healthy Infants at 6, 10 and 14 Weeks of Age

One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials

Biological: Quinvaxem in single dose vials

Eligibility

Ages Eligible for Study:

42 Days to 64 Days

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

A male or female between, and including, 42 and 64 days of age at the time of the first vaccination

Written informed consent obtained from parents/legal guardians of the subject

Free of obvious health problems as established by medical history and/or clinical examination before entering the study

HepB vaccination at birth (within 48 hours)

Available for all scheduled study visits

Exclusion Criteria:

Use of any investigational drug or any investigational vaccine in the 30 days preceding the first dose of study vaccine, or their planned use during the study period and safety follow-up

Planned administration of a vaccine not foreseen by the Study Protocol

Known or suspected impairment of immune function, known HIV-positivity; actively receiving immunosuppressive therapy, or in receipt of systemic immunosuppressive therapy in the one month prior to study entry (note: inhaled and topical steroids are allowed)

History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity to any vaccine component or to products containing mercury compounds, such as thiomersal

Clinically significant acute infection

Clinically significant acute illness

Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Participation in another clinical study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917357